Sr Manager, Regulatory Affairs at Baxter
Deerfield, IL 60015, USA -
Full Time


Start Date

Immediate

Expiry Date

14 Nov, 25

Salary

187000.0

Posted On

14 Aug, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Good communication skills

Industry

Marketing/Advertising/Sales

Description

THIS IS WHERE YOU SAVE AND SUSTAIN LIVES

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You’ll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.
Baxter’s products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.
Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.
Join us at the intersection of saving and sustaining lives— where your purpose accelerates our mission.
Baxter is committed to supporting the needs for flexibility in the workplace. We do so through our flexible workplace policy which includes a minimum of 3 days a week onsite. This policy provides the benefits of connecting and collaborating in-person in support of our Mission.
We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all our employees, and we strive to be more transparent with our pay practices. To that end, this position has a base salary range of $104,000 to $143,000, plus an annual incentive bonus, commission target, and equity target. The above range represents the expected base salary range for this position. The actual salary may vary based upon several factors including, but not limited to, relevant skills/experience, time in the role, business line, and geographic/office location.
Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.
Your role at Baxter:
Provides business, execution and technical leadership for major, high-complexity efforts (top corporate initiatives) within the Baxter regulatory organization while leading multiple teams through all phases initiatives. The Sr. Manager facilitates cross functional cooperation to achieve results and collaborates with marketing, legal, regulatory affairs, quality, supply chain, manufacturing, labeling, purchasing, and division PMOs to develop and achieve results. This person will interact with, and influence senior internal and external stakeholders including regulatory authorities. Sr. Manager will make launch date commitments to businesses and manage stakeholder expectations with regard to Baxter deliverables during the project. This person will serve as a champion of product lifecycle management processes.

What you will be doing

  • Experience with regulatory compliance activities surrounding EU MDR, EUDAMED, GUDID, UDI, SPL, and other requirements across various jurisdictions in the world.
  • Leading teams to execute product submissions.
  • P articipate on cross-functional teams and collaborating on innovative strategies for accelerating time to market and regulatory approvals.
  • Monitor and assess impact of new regulations and provide input to draft regulations and guidance. Mentor and coach teams and to support business units on various regulatory initiatives.
  • Develops and executes regulatory plans aligned with business strategy for complex projects including new products and maintenance of licenses/ authorizations for existing marketed products
  • • Identifies and prioritizes key areas of risk, and develop & implement appropriate mitigation plans
  • • Establishes appropriate communication within RA, with Marketing, and with other functions primarily at project level and favor proactive communication
  • • Ensures regulatory strategy and deliverables are aligned with project teams and business objectives • Leads regulatory activities related to their portfolio of products
  • • Develops and documents sound regulatory decisions and justification
  • Leads team in defining strategies
  • Provides clear direction on product lifecycle management requirements to meet expectations of external customers and business stakeholders
  • Interacts through updates and reviews with all functions and levels of management ensuring effective ongoing communications across teams and stakeholders
  • Ensures identification and communication of risks, development of risk plan and proactive management of risk response strategies
  • Anticipates potential conflict situations for proactive solutions and manages conflict situations to result in win-win outcomes
  • Works closely with business stakeholders to understand business pain points and helps identify business solutions and/or capabilities required to address specific business challenges
  • Maximizes business results through continuous improvement in organization’s ability to execute

What do you bring

  • Minimum MBA/MS or bachelor’s with equivalent plus 10-15 years’ experience and 5 years of regulatory related experience with demonstrated success leading multi-site, global or enterprise-wide initiatives in the medical products industry.
  • Business acumen
  • Role model of Vital Behaviors and Leadership Essentials
  • Strong leadership skills
  • Medical device industry and/or regulatory compliance work experience a plus
  • Experience in regulatory affairs

Baxter is committed to supporting the needs for flexibility in the workplace. We do so through our flexible workplace policy which includes a minimum of 3 days a week onsite. This policy provides the benefits of connecting and collaborating in-person in support of our Mission.
We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all our employees, and we strive to be more transparent with our pay practices. To that end, this position has a base salary range of $136,000 to $187,000, plus an annual incentive bonus, commission target, and equity target. The above range represents the expected base salary range for this position. The actual salary may vary based upon several factors including, but not limited to, relevant skills/experience, time in the role, business line, and geographic/office location.
Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.

Responsibilities
  • Experience with regulatory compliance activities surrounding EU MDR, EUDAMED, GUDID, UDI, SPL, and other requirements across various jurisdictions in the world.
  • Leading teams to execute product submissions.
  • P articipate on cross-functional teams and collaborating on innovative strategies for accelerating time to market and regulatory approvals.
  • Monitor and assess impact of new regulations and provide input to draft regulations and guidance. Mentor and coach teams and to support business units on various regulatory initiatives.
  • Develops and executes regulatory plans aligned with business strategy for complex projects including new products and maintenance of licenses/ authorizations for existing marketed products
  • • Identifies and prioritizes key areas of risk, and develop & implement appropriate mitigation plans
  • • Establishes appropriate communication within RA, with Marketing, and with other functions primarily at project level and favor proactive communication
  • • Ensures regulatory strategy and deliverables are aligned with project teams and business objectives • Leads regulatory activities related to their portfolio of products
  • • Develops and documents sound regulatory decisions and justification
  • Leads team in defining strategies
  • Provides clear direction on product lifecycle management requirements to meet expectations of external customers and business stakeholders
  • Interacts through updates and reviews with all functions and levels of management ensuring effective ongoing communications across teams and stakeholders
  • Ensures identification and communication of risks, development of risk plan and proactive management of risk response strategies
  • Anticipates potential conflict situations for proactive solutions and manages conflict situations to result in win-win outcomes
  • Works closely with business stakeholders to understand business pain points and helps identify business solutions and/or capabilities required to address specific business challenges
  • Maximizes business results through continuous improvement in organization’s ability to execut
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